Pfizer’s Mylotarg looks set to return to the EU market after a gap of several years, with the CHMP backing its approval a first-line treatment for acute myeloid leukaemia (AML) in patients aged 15 and over.
Mylotarg (gemtuzumab ozogamicin) was the first antibody-drug conjugate to reach the market nearly two decades ago, but was voluntarily withdrawn from the market in Europe and the US in 2010 after a post-marketing study raised questions about its safety and efficacy.
Pfizer kept producing Mylotarg in order to make it available on compassionate use in Europe and this gave independent investigators the opportunity to continue to study the drug.
The company also carried out an additional clinical trial (ALFA-0701) using an alternative fractionated dosing schedule designed to improve the drug’s tolerability and – armed with positive results showing CD33-positive patients who received Mylotarg in combination with chemotherapy went longer without complications than those who received chemotherapy alone – re-filed Mylotarg with the EMA and FDA last year. The FDA approved the drug last September.
“There is an urgent need to improve outcomes for leukaemia patients in Europe,” said Pfizer’s chief development officer Mace Rothenberg. “If approved, the addition of Mylotarg to standard chemotherapy will provide an important new treatment option for patients with AML who would typically be treated with chemotherapy alone.”
CHMP round-up
At its meeting last week, the CHMP also backed approval of Ammtek’s Amiglidia (glibenclamide) as the first-ever medicine to treat neonatal diabetes and Biocryst’s Alpivir (peramivir) infusion for the treatment of uncomplicated influenza.
There was worse news for Puma Biotechnology – which has its application to market Nerlyx (neratinib) for breast cancer turned down – and also Pfizer whose application to extend the indications of Sutent (sunitinib) to include it use to prevent the return of kidney cancer in patients who have had surgery and are at high risk of their cancer coming back.
The CHMP also gave positive opinions to: a new maintenance indication for AstraZeneca and Merck & Co’s PARP inhibitor Lynparza (olaparib) in ovarian cancer; the use of Swedish orphan Biovitrum’s Kineret (anakinra) in rare inflammatory condition Still’s disease; and Pfizer’s Bosulif (bosutinib) as a treatment for newly-diagnosed Philadelphia chromosome-positive chronic myelogenous leukaemia (CML).